Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study

Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study

Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children.

Objectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence.

Methods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period.

Significance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.

Inclusion Criteria:

• Children 4-18 years old with fecal incontinence for a period greater than 6 months.
• FI frequency of ≥ 3 episodes/week.
• After appropriate medical evaluation, FI cannot be explained by another medical condition.
• Normal colonic transit study, defined as passage of 80% of markers on day
• Normal RAIR on anorectal manometry

Exclusion Criteria:

• Patients currently fulfilling rome IV criteria for functional constipation.
• Patients with evidence of fecal retention.
• Patients who had had good response to treatment for overflow incontinence.
• Absent RAIR on anorectal manometry.
• Any radiologic evidence of dochylosigmoid or distended colon.
• Any known organic condition that may affect bowel transit.